510(k) · Cleared
Recalled · Class II · 2013Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Aug 13, 2012 as substantially equivalent to K063847 (Fujinon, Inc., 2007) and 1 other predicate after a 181-day review. Its family tree reaches back 6 generations to 1982. 1 of the 30 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2012
- Review
- 181 days
- Class
- Class II
- Product code
- FDS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K822846 (1982). 25 ancestors in all, the oldest K812810 (1981). 4 later devices descend from it, 1 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 5 generations backK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 4 generations backK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · Recalled
- 3 generations backK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- 2 generations backK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- 1 generation backK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- This deviceK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK183433 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK221238 FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK221952 Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation · 2022
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-234 generations back · 1985
Most influential descendants
Showing 4 of 4 · See all- K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018 · cites it directly3descendants
- K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019 · 2 generations on2descendants
- K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation · 2022 · 3 generations on0descendants
- K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −5 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| −4 | K961564 | EG-2940, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −3 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −2 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| −1 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| 0 (this device) | K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 | Fujinon, Inc. | 2012 | — |
| +1 | K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018 | — |
| +2 | K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019 | — |
| +3 | K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022 | — |
| +3 | K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 1 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Summary page 1…E DESCRIPTION Fujinon/Fujifilmn Ultrasonic Endloscopes EG-530ULR2 and EG-530UT2 are modified versions of our previously-cleared EG-53OUR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper g… | 2007 |
| * | K111243 | Fujinon Ultrasonic ProcessorSummary page 2…cessor K063847 (EG-530UR, EG-530UT and SU-7000)I Pujinon Ultrasonic Processor SU-8000 IKi111243 See Section 12 Comparison Matrix for detailed comparison. V. CONCLUSION Fujinon/Fujifllm Ultrasonic endosco… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181763 | FUJIFILM Ultrasonic Endoscope | 2018 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2013 | Class II | Z-0112-2014 | Unknown/Undetermined by firm | A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K850020Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Pentax Precision Instrument Corp. · 1985 · 4 generations back · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 11 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181763 (Fujifilm Corporation, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K063847.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
Fujinon/Fujiflm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujmflm ultrasonic processor. This product is not intended for use on children and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120446
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026